BMC Surgery (Oct 2024)
The efficacy of wrapping with polyglycolic acid mesh and fibrin glue in preventing clinically relevant pancreatic fistula after minimally invasive distal pancreatectomy (WRAP Study): study protocol for a multicenter randomized controlled trial in Japan
- Hayato Baba,
- Atsushi Oba,
- Kimitaka Tanaka,
- Takayuki Miura,
- Daisuke Ban,
- Motonori Edanami,
- Yoshiya Ishikawa,
- Katsuhisa Ohgi,
- Haruyoshi Tanaka,
- Ryuta Shintakuya,
- Naoki Ikenaga,
- Tetsuya Ijichi,
- Yoshitaka Kiya,
- Ryo Muranushi,
- So Yamaki,
- Naoki Miyazaki,
- Shintaro Takeuchi,
- Shuichi Aoki,
- Takahiro Mizui,
- Masayuki Tanaka,
- Hiroki Ueda,
- Hideyuki Dei,
- Hideki Takami,
- Kenjiro Okada,
- Kohei Nakata,
- Yuko Mataki,
- Hiroaki Osakabe,
- Kazuto Shibuya,
- Daisuke Hashimoto,
- Yosuke Inoue,
- Satoshi Hirano,
- Michiaki Unno,
- Minoru Esaki,
- Minoru Kitago,
- Keiichi Akahoshi,
- Teiichi Sugiura,
- Tomoki Ebata,
- Kenichiro Uemura,
- Masafumi Nakamura,
- Takao Otsuka,
- Yuichi Nagakawa,
- Tsutomu Fujii,
- Sohei Satoi,
- Yu Takahashi
Affiliations
- Hayato Baba
- Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Atsushi Oba
- Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Kimitaka Tanaka
- Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University
- Takayuki Miura
- Department of Surgery, Tohoku University Graduate School of Medicine
- Daisuke Ban
- Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital
- Motonori Edanami
- Departments of Surgery, Keio University School of Medicine
- Yoshiya Ishikawa
- Department of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University
- Katsuhisa Ohgi
- Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007
- Haruyoshi Tanaka
- Department of Surgery, Nagoya University Hospital
- Ryuta Shintakuya
- Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
- Naoki Ikenaga
- Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
- Tetsuya Ijichi
- Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences
- Yoshitaka Kiya
- Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
- Ryo Muranushi
- Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630
- So Yamaki
- Department of Pancreatobiliary Surgery, Kansai Medical University
- Naoki Miyazaki
- Division of Clinical Research Planning and Strategy, Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Shintaro Takeuchi
- Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University
- Shuichi Aoki
- Department of Surgery, Tohoku University Graduate School of Medicine
- Takahiro Mizui
- Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital
- Masayuki Tanaka
- Departments of Surgery, Keio University School of Medicine
- Hiroki Ueda
- Department of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University
- Hideyuki Dei
- Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007
- Hideki Takami
- Department of Surgery, Nagoya University Hospital
- Kenjiro Okada
- Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
- Kohei Nakata
- Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
- Yuko Mataki
- Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences
- Hiroaki Osakabe
- Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
- Kazuto Shibuya
- Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630
- Daisuke Hashimoto
- Department of Pancreatobiliary Surgery, Kansai Medical University
- Yosuke Inoue
- Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research
- Satoshi Hirano
- Department of Gastroenterological Surgery II, Faculty of Medicine, Hokkaido University
- Michiaki Unno
- Department of Surgery, Tohoku University Graduate School of Medicine
- Minoru Esaki
- Department of Hepatobiliary and Pancreatic Surgery, National Cancer Center Hospital
- Minoru Kitago
- Departments of Surgery, Keio University School of Medicine
- Keiichi Akahoshi
- Department of Hepatobiliary and Pancreatic Surgery, Graduate School of Medicine, Tokyo Medical and Dental University
- Teiichi Sugiura
- Division of Hepato-Biliary-Pancreatic Surgery, Shizuoka Cancer Center, 1007
- Tomoki Ebata
- Department of Surgery, Nagoya University Hospital
- Kenichiro Uemura
- Department of Surgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
- Masafumi Nakamura
- Department of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University
- Takao Otsuka
- Department of Digestive Surgery, Breast and Thyroid Surgery, Kagoshima University Graduate School of Medical and Dental Sciences
- Yuichi Nagakawa
- Department of Gastrointestinal and Pediatric Surgery, Tokyo Medical University
- Tsutomu Fujii
- Department of Surgery and Science, Faculty of Medicine, Academic Assembly, University of Toyama, 2630
- Sohei Satoi
- Department of Pancreatobiliary Surgery, Kansai Medical University
- Yu Takahashi
- Division of Hepatobiliary and Pancreatic Surgery, Cancer Institute Hospital, Japanese Foundation for Cancer Research
- DOI
- https://doi.org/10.1186/s12893-024-02610-0
- Journal volume & issue
-
Vol. 24,
no. 1
pp. 1 – 9
Abstract
Abstract Background Postoperative pancreatic fistula (POPF) continues to be the most common complication after distal pancreatectomy (DP). Recent advancements in surgical techniques have established minimally invasive distal pancreatectomy (MIDP) as the standard treatment for various conditions, including pancreatic cancer. However, MIDP has not demonstrated a clear advantage over open DP in terms of POPF rates, indicating the need for additional strategies to prevent POPF in MIDP. This trial (WRAP study) aims to evaluate the efficacy of wrapping the pancreatic stump with polyglycolic acid (PGA) mesh and fibrin glue in preventing clinically relevant (CR-) POPF following MIDP. Methods This multicenter, randomized controlled trial will include patients scheduled for laparoscopic or robotic DP for tumors in the pancreatic body and/or tail. Eligible participants will be centrally randomized into either the control group (Group A) or the intervention group (Group B), where the pancreatic stump will be reinforced by PGA mesh and fibrin glue. In both groups, pancreatic transection will be performed using a bioabsorbable reinforcement-attached stapler. A total of 172 patients will be enrolled across 14 high-volume centers in Japan. The primary endpoint is the incidence of CR-POPF (International Study Group of Pancreatic Surgery grade B/C). Discussion The WRAP study will determine whether the reinforcement of the pancreatic stump with PGA mesh and fibrin glue, a technique whose utility has been previously debated, could become the best practice in the era of MIDP, thereby enhancing its safety. Trial registration This trial was registered with the Japan Registry of Clinical Trials on June 15, 2024 (jRCTs032240120).
Keywords
- Distal pancreatectomy
- Fibrin glue
- Minimally invasive surgery
- Polyglycolic acid mesh
- Pancreatic fistula
